Oral Nutritional Supplements in Treatment of Elderly Mild-to-Moderate COVID-19

NCT05629975 | Unknown DMC

• 1 other identifier: SBKT-2022-201
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

The coronavirus disease 2019 (COVID-19) pandemic has seriously threatened public health worldwide. Nutritional supplements may have a positive influence on the recovery of patients with viral infection. This study aimed to assess the influence of oral nutritional supplements (ONSs) on the biochemical parameters of elderly patients with mild-to-moderate COVID-19. This clinical trial will be conducted on 145 elderly patients with mild-to-moderate COVID-19. Patients in the intervention group (n=74) received nutritional powder (vitamins, minerals, dietary fiber, polyphenols, omega-3, amino acids, and probiotics) for 14 days. Cases in the control group (n=71) took the placebo, except for nutritional powder, and they received the same treatment. Biochemical parameters were measured before and two weeks after intervention.

Conditions

Nutrition, Healthy

Keywords

Oral nutritional supplements

Outcome Measures

Primary Outcomes (5)

• coagulation function and blood cell count (CBC)

  white blood cell (WBC) count(\*109/L)

  2 weeks

• kidney functions

  blood urea nitrogen (BUN)(mg/L)

  2 weeks

• ABG parameters

  oxygen partial pressure (PO2)(mmHg)

  2 weeks

• serum electrolytes

  potassium (K+)(mmol/L)

  2 weeks

• inflammatory indices

  interleukin-8 (IL-8)(pg/mL)

  2 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

In addition to the normal diet in the hospital, patients in the intervention group received a package of nutritional powder in the morning and evening of every day, and each package was diluted with 500 ml of water. Each package contained L-arginine (750 mg), methionine (300 mg), glutamine (5 g), plant protein (10 g), vitamin B12 (1 ug), vitamin C (50 mg), vitamin D (2000 IU), vitamin A (300 mg), folic acid (5 mg), omega-3 fatty acid (1 g), zinc (20 mg), magnesium (400 mg), selenium (100 mcg), whole wheat fiber (5 g), carotenoid (3 mg), curcumin supplement (500 mg). Probiotics included orally administration of clostridium butyricum\& bifidobacterium (500 mg) every day for 7 days.

Dietary Supplement: Oral Nutritional Supplements

Control group

NO INTERVENTION

Patients in the control group received normal diet provided by the hospital.

Interventions

Oral Nutritional Supplements DIETARY_SUPPLEMENT

Each package contained L-arginine (750 mg), methionine (300 mg), glutamine (5 g), plant protein (10 g), vitamin B12 (1 ug), vitamin C (50 mg), vitamin D (2000 IU), vitamin A (300 mg), folic acid (5 mg), omega-3 fatty acid (1 g), zinc (20 mg), magnesium (400 mg), selenium (100 mcg), whole wheat fiber (5 g), carotenoid (3 mg), curcumin supplement (500 mg). Probiotics included orally administration of clostridium butyricum\& bifidobacterium (500 mg) every day for 7 days.

Intervention group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COVID-19-positive was confirmed by reverse transcription-polymerase chain reaction (RT-PCR);
• Mild-to-moderate COVID-19 patients who aged 60-90 years old;
• Consistency with the indication of enteral nutrition;
• The time from diagnosis of COVID-19 to hospitalization was less than 24 h.

You may not qualify if:

• Oxygen saturation \< 93% or mechanical ventilation was required;
• Systemic diseases (malignant tumors, autoimmune diseases, liver or kidney diseases);
• Participation in other clinical trials within 3 months;
• History of allergy to nutrients in the trial.

Sponsors & Collaborators

• Shanghai Tongji Hospital, Tongji University School of Medicine: lead

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Yongxin Zhou, Dr

  Shanghai Tongji Hospital, Tongji University School of Medicine

  STUDY CHAIR

Central Study Contacts

Wenli Wang, Dr

CONTACT

13761295864; anderson840913@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 29, 2022
• Study Start: November 30, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share